title: Analytical performance of Cervista HPV 16/18 genotyping test for cervical cytology samples.
abstract: BACKGROUND
  Human papillomavirus (HPV) types 16 and 18 are the 2 most frequent types associated with cervical cancer. Identifying their presence or absence in cervical samples may assist in triaging women for subsequent management. The Cervista HPV 16/18 genotyping test specifically detects the presence of HPV 16 and 18 in ThinPrep cervical specimens.
  
  
  OBJECTIVE
  The objective was to establish the analytical performance of the CERVISTA HPV 16/18 genotyping test.
  
  
  METHODS
  These studies were performed in support of a regulatory submission to the US Food and Drug Administration. Here we report the analytical sensitivity (limit of detection), accuracy compared to consensus L1 gene PCR/bi-directional sequencing, precision, reproducibility, and cross-reactivity (specificity) of the genotyping test.
  
  
  RESULTS
  Analytical sensitivity for detection of HPV 16 and 18 ranged between 625 and 1250 copies/reaction for both types. When compared to PCR/sequencing for women with atypical squamous cells of undetermined significance cytology, the positive percent agreement was 94.1% (95% confidence interval [CI], 89.8-96.7) and the negative percent agreement was 85.7% (95% CI, 82.4-88.4). The test demonstrated high within-laboratory and inter-operator precision. Reproducibility within sites and between 3 testing sites resulted in 100% agreement with expected results (150 positive, 90 negative results). The genotyping test did not exhibit cross-reactivity to DNA from common low-risk HPV types and other microorganisms found in the human female reproductive tract.
  
  
  CONCLUSIONS
  These analytical performance data support the use of CERVISTA HPV 16/18 genotyping test for the detection and differentiation of HPV 16 and 18 in ThinPrep cervical cytology specimens.
authors.affiliation: Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, 4053 West Dublin Granville Road, Dublin, OH 43017, USA. Deborah.Bartholomew@osumc.edu
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Bartholomew
authors.forename: Ronald D
authors.initials: RD
authors.lastname: Luff
authors.forename: Neil B
authors.initials: NB
authors.lastname: Quigley
authors.forename: Michelle
authors.initials: M
authors.lastname: Curtis
authors.forename: Marilyn C
authors.initials: MC
authors.lastname: Olson
mesh_terms: D002584:Cervix Uteri / Q000821:virology*; D003429:Cross Reactions; D004279:DNA, Viral / Q000235:genetics / Q000302:isolation & purification; D005260:Female; D005838:Genotype; D052162:Human papillomavirus 16 / Q000235:genetics / Q000302:isolation & purification*; D052161:Human papillomavirus 18 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D058889:Molecular Typing; D030361:Papillomavirus Infections / Q000235:genetics / Q000821:virology*; D016133:Polymerase Chain Reaction; D011247:Pregnancy; D011248:Pregnancy Complications / Q000235:genetics; D011446:Prospective Studies; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014481:United States; D002583:Uterine Cervical Neoplasms / Q000235:genetics / Q000821:virology*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000235:genetics / Q000821:virology*
chemical_list: D004279:DNA, Viral